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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE WATCHMAN® ACCESS SYSTEM; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
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BOSTON SCIENTIFIC - MAPLE GROVE WATCHMAN® ACCESS SYSTEM; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL Back to Search Results
Model Number M635TC20060
Device Problem Leak/Splash (1354)
Patient Problem Blood Loss (2597)
Event Date 08/02/2016
Event Type  Injury  
Manufacturer Narrative
Age at time of event: over 18 years old.(b)(4).
 
Event Description
It was reported a hemostasis valve leak occurred.A left atrial appendage (laa) closure procedure was being performed.The watchman ® access system was being advanced over the guidewire into the la.It was noticed that the hemostasis valve was leaking blood.The hemostasis valve was not too tight and the physician attempted to close the valve to stop the leaking, but was unsuccessful and the patient experienced 300 ml of blood loss.The physician introduced an unknown 8f sheath as an auxiliary device to stop the leaking and the procedure was completed successfully.The patient's condition was stable.
 
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of the watchman access sheath (was).Blood was on the device and the valve was opened as received.The hub, shaft, and tip were examined.Microscope examination of the valve did not reveal any damage or irregularities; however, it was noted that the threads of the was were damaged/cross threaded.It could not be determined when the thread damage occurred.Multiple kinks were found on the shaft of the device.The tip was damaged with inner liner delamination.Functional testing of the valve confirmed the ability to completely close the valve with minimal forward force.Water was injected into the was by attaching a syringe filled with water.There were no leaks or air bubbles observed during water injection.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).
 
Event Description
It was reported a hemostasis valve leak occurred.A left atrial appendage (laa) closure procedure was being performed.The watchman ® access system was being advanced over the guidewire into the la.It was noticed that the hemostasis valve was leaking blood.The hemostasis valve was not too tight and the physician attempted to close the valve to stop the leaking, but was unsuccessful and the patient experienced 300 ml of blood loss.The physician introduced an unknown 8f sheath as an auxiliary device to stop the leaking and the procedure was completed successfully.The patient's condition was stable.
 
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Brand Name
WATCHMAN® ACCESS SYSTEM
Type of Device
SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
Manufacturer Contact
linda leimer
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key5903394
MDR Text Key52968082
Report Number2134265-2016-07537
Device Sequence Number1
Product Code NGV
Combination Product (y/n)N
Reporter Country CodeCN
PMA/PMN Number
P130013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/02/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/25/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2018
Device Model NumberM635TC20060
Device Catalogue NumberTC20060
Device Lot Number18756167
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/09/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/17/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/26/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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